Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 1

Alcohol Use Disorder Clinical Trial

Official title:

Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement With an Underserved Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03883126
• Other study ID #: 54073
• Secondary ID: R01AA026605
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2020
• Est. completion date: November 2024

Study information

• Verified date: July 2023
• Source: University of Kentucky
• Contact: Mikhail N Koffarnus, PhD
• Phone: 8595332749
• Email: healthful[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Directly reinforcing abstinence from alcohol with monetary incentives is an effective treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical measures of abstinence limit the dissemination of this treatment approach. The goal of this study is to use technological advancements to remotely, accurately, and securely monitor alcohol use with a newly developed smartphone app and breathalyzer. This treatment approach has the potential to facilitate the dissemination of an effective, evidence-based treatment for alcohol dependence to a broader population whose treatment needs are not currently being adequately met.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Meet Diagnostic and Statistical Manual (DSM)-5 criteria for alcohol use disorder

• Average 3 or more heavy drinking days (=5 drinks in one occasion for men, =4 for women) per week for the past month on the Timeline Follow-back.

• Must endorse alcohol as their primary drug of use.

• Express a desire to abstain from drinking.

Exclusion Criteria:

• Are currently enrolled in an alcohol treatment program (not including attendance at Alcoholics Anonymous or similar community support meetings).

• Score 23 or greater on the Alcohol Withdrawal Symptom Checklist, a score indicating that medication would be likely required to manage alcohol detoxification.

• Pregnant women, lactating women, or women who are planning to become pregnant in the next 15 months.

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism

Intervention

Behavioral:
• Contingency management
Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol.
• Contingency management
Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.

Locations

Country	Name	City	State
United States	Nationwide Online Enrollment from the Unversity of Kentucky	Lexington	Kentucky
United States	University of Kentucky Turfland: In-person enrollment	Lexington	Kentucky
United States	Carilion Clinic: In person-enrollment	Roanoke	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Mikhail N Koffarnus	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pattern of abstinence from alcohol during intervention	Breathalyzer assessments will be collected during the treatment period. This outcome measure will consist of the percentage of days without alcohol use as detected by the breathalyzers.	up to 66 weeks
Primary	Treatment acceptability	Participant ratings of treatment acceptability on a customized questionnaire will be collected during assessment sessions	A total of 12 assessment sessions spanning over a 66 week period.